RELATIONSHIP OF ADVERSE EVENTS TO STUDY DRUG Sample Clauses

RELATIONSHIP OF ADVERSE EVENTS TO STUDY DRUG. The causal relationship of the investigational product to the AE(s) should be characterized as: Not Related: There is no reasonable possibility that the AE was caused by or attributed to the investigational product Related: There is a reasonable possibility that the AE was caused by or attributed to the investigational product. A causal relationship cannot be ruled out. Definition of “No Reasonable Possibility” The assessment term, “no reasonable possibility”, can only be applied to those AEs which, after careful consideration, are clearly due to extraneous causes (disease, environment, etc.) or to those AEs which, after careful medical consideration at the time they are evaluated, are judged to be unrelated to the study drug. An AE may be considered as being meeting the definition of “no reasonable possibility” if data are available to identify a clear alternative cause for the AE other than study drug; such as the patient’s clinical state, concomitant therapy, and/or other interventions or the AE/SAE has no plausible temporal relationship to administration of study drug. Definition of “Reasonable Possibility” The assessment term, “reasonable possibility”, can only be applied to those AEs which, after careful medical consideration at the time they are evaluated, a connection with the study drug administration cannot be ruled out with certainty or is felt with a high degree of certainty to be related to the study drug. An AE may be considered as meeting the definition of “reasonable possibility” if there is a plausible temporal relationship between the onset of the AE/SAE and study drug administration and the AE/SAE cannot be readily explained by the patient’s clinical state, intercurrent illness, or concomitant therapies; and/or the AE/SAE follows a known pattern of response to study drug; and/or the AE/SAE abates or resolves upon discontinuation of study drug or dose reduction and, if applicable, reappears upon re- challenge.
Sample 1
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